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FDA 510(k)

NA LATEX MYOGLOBIN TEST

K-Number: K902154 · 1990-06-01

ApplicantBehring Diagnostics, Inc.
Decision Date1990-06-01
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NA LATEX MYOGLOBIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-06-01 under 510(k) number K902154. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NA LATEX MYOGLOBIN TEST?

NA LATEX MYOGLOBIN TEST is a medical device that received FDA 510(k) clearance on 1990-06-01. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K902154.

When did NA LATEX MYOGLOBIN TEST receive FDA 510(k) clearance?

NA LATEX MYOGLOBIN TEST received FDA 510(k) clearance on 1990-06-01, under 510(k) number K902154.

Who is the listed applicant for NA LATEX MYOGLOBIN TEST?

The FDA 510(k) record lists Behring Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NA LATEX MYOGLOBIN TEST?

The FDA product code for NA LATEX MYOGLOBIN TEST is DDR.

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Other records listing Behring Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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Related Devices (Code: DDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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